Brand name · Mometasone furoate and formoterol fumarate dihydrate
Dulera: adverse event reports filed with FDA
7,259 reports list it as a suspect or interacting product, 2010–2026. Class: Corticosteroid. Also reported as Dulera Tablet, Dulera Oral Inhalation, Dulera Inhaler.
- 7,259
- reports as suspect product
- 0% of all reports · about 459 a year
- 24
- reports, 12 months to June 2026
- 37 in the 12 months before
- 13.2%
- marked serious by the reporter
- 77.7% across the class
- 0.8%
- record death among outcomes, as reported
- 59 reports · not verified by FDA
7,259 adverse event reports received by FDA list the brand name Dulera (mometasone furoate and formoterol fumarate dihydrate) as a suspect or interacting product, from September 2010 to April 2026. A further 8,550 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 24 reports listed it, down 35% from 37 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 459 reports a year and 0% of the 20,646,523 reports in the database, and 0.9% of the reports for the corticosteroid class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded product quality issue (42.1%), no adverse event (37.4%) and drug dose omission (27.2%). A report can list several reactions, so shares add to more than 100%; 440 different terms appear across these reports. Product quality issue is recorded in 42.1% of these reports, a larger share than in the median corticosteroid drug (1.4%).
13.2% of the reports are marked serious by the reporter (77.7% across the class); 0.8% record death among the outcomes and 5.1% record hospitalisation, as reported. 41.6% of the reports came from consumers, and the largest patient age group is 45 to 64 (11.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Dulera reports recording the termmedian drug in corticosteroid
- Product quality issuea problem with the product itself42.1%3,059
- No adverse eventno adverse event was reported37.4%2,717
- Drug dose omissiona dose was missed27.2%1,972
- Poor quality device used15%1,089
- Dyspnoeashortness of breath12.6%914
- Device malfunctionthe device did not work properly9.5%690
- Incorrect dose administeredthe wrong dose was given6.9%504
- Product container issuea problem with the container5.7%413
- Coughcough5.4%393
- Product dose omission issuea dose was missed5.2%381
- Product use issuea problem in how the product was used4.9%353
- Circumstance or information capable of leading to medication errora situation that could lead to a medication error4.8%347
- Drug ineffectivethe medicine did not work as expected4.7%343
- Product dose omissiona dose was missed4.1%296
- Asthmaasthma3.8%274
- Underdoseless than the intended dose3.6%259
- Wheezingwheezing2.8%206
- Dysphoniaa hoarse voice2.6%186
- Wrong technique in product usage processthe product was used in the wrong way2.5%182
- Headachehead pain2.1%155
- Chest discomfortchest discomfort1.9%136
- Product use in unapproved indicationused for a purpose not on the label1.8%130
- Inappropriate schedule of drug administrationthe medicine was taken at the wrong times1.7%122
- Dizzinesslight-headedness or unsteadiness1.6%114
- Adverse eventan unwanted medical event, type not specified1.4%104
- Chest painchest pain1.4%103
- Off label useused for a purpose or in a way not on the label1.4%98
- Malaisegeneral feeling of being unwell1.3%97
- Tremorshaking1.2%87
Top 30 of 440 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 74 drugs in the corticosteroid class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 808,789 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Asthma | 2,004 | 27.6% |
| Chronic obstructive pulmonary disease | 527 | 7.3% |
| Dyspnoea | 64 | 0.9% |
| Emphysema | 50 | 0.7% |
| Bronchitis | 37 | 0.5% |
| Cough | 22 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 7,259 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Dulera reports |
|---|---|---|
| Singulair | 300 | 4.1% |
| Tiotropium bromide | 236 | 3.3% |
| Albuterol | 187 | 2.6% |
| Albuterol sulfate | 173 | 2.4% |
| Proair Hfa | 149 | 2.1% |
| Proventil | 128 | 1.8% |
| Symbicort | 125 | 1.7% |
| Prednisone | 110 | 1.5% |
| Advair Hfa | 89 | 1.2% |
| Aspirin | 87 | 1.2% |
Other products listed in reports where Dulera is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Dulera | Corticosteroid | All reports |
|---|---|---|---|
| Reports as suspect product | 7,259 | 808,789 | 20,646,523 |
| Share of that pool | — | 0.9% | 0% |
| Reports, latest 12 months | 24 | — | 1,332,454 |
| Marked serious | 13.2% | 77.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 8 | 146 | 91 |
| Hospitalisation recorded, per 1,000 reports | 51 | 336 | 213 |
| Consumer-filed share | 41.6% | 29.1% | 45.8% |
| Top term, share of reports | Product quality issue 42.1% | median 1.4% | 0.6% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."
Other drugs in the corticosteroid class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Prednisone | generic | 183,867 | 15,614 | 91.4% |
| Dexamethasone | generic | 129,677 | 9,216 | 95.1% |
| Prednisolone | generic | 87,806 | 6,624 | 97.6% |
| Methylprednisolone | generic | 49,537 | 4,430 | 95.2% |
| Symbicort | brand | 39,119 | 1,177 | 50.6% |
| Breo Ellipta | brand | 22,220 | 628 | 31.7% |
| Hydrocortisone | generic | 21,263 | 2,386 | 89.5% |
| Advair Diskus | brand | 20,518 | 120 | 29% |
| Advair Hfa | brand | 19,622 | 589 | 54.9% |
| Budesonide | generic | 14,714 | 1,083 | 82.2% |
| Desoximetasone | generic | 12,209 | 1,525 | 99.2% |
| Flovent | brand | 10,772 | 171 | 42.1% |
| Methylprednisolone sodium succinate | generic | 10,772 | 1,630 | 97.8% |
| Solu-medrol | generic | 10,288 | 432 | 88.8% |
| Cipro | brand | 9,791 | 108 | 57.3% |
Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.
Questions about Dulera reports
How many adverse event reports has FDA received for Dulera?
7,259 reports list Dulera as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 24 of them arrived in the latest 12 months. Another 8,550 list it only as a concomitant medication.
What reactions are recorded in Dulera reports?
product quality issue (42.1%), no adverse event (37.4%), drug dose omission (27.2%), poor quality device used (15%) and dyspnoea (12.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Dulera was responsible.
How serious are the reports?
13.2% are marked serious by the reporter. Among the outcomes recorded, 0.8% of reports include death and 5.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
consumer or non-health professional (41.6%), physician (31.1%) and pharmacist (20.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Dulera rising?
24 reports in the 12 months to June 2026, down 35% from 37 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Dulera was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Dulera?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dulera as a suspect or interacting product; reports listing it only as a concomitant medication (8,550) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.